Marching to Different Drummers: Health Advocacy Groups in Canada and Funding from the Pharmaceutical Industry pptx

Marching to Different Drummers: Health Advocacy Groups in Canada and Funding from the Pharmaceutical Industry by Sharon Batt Women and Health Protection, January, 2005 I.. Organizations

Marching to Different Drummers: Health Advocacy Groups in Canada and Funding from the Pharmaceutical Industry

by Sharon Batt Women and Health Protection, January, 2005

I Introduction

The closeness of industry involvement in the health advocacy movement is

beginning to undermine the good names of health campaigners, weakening

their public reputation

- Health and Social Campaigners’ News, U.K., April 20041

Pharmaceutical reps will coach citizens how to lobby to get the new drug on

the formulary, said Armstrong “The pharmaceutical companies figured out

who the real decision-makers are – the public.”

- Wendy Armstrong of the Consumers’ Association of Canada and

PharmaWatch, quoted in The Edmonton Journal,

October, 20032

“The money has to come from somewhere,” Mr Stein said, “And thank God

it’s coming from these [pharmaceutical] companies because it’s not coming

from anywhere else.”

- Barry Stein of the Colorectal Cancer Society of Canada,

quoted in the Globe and Mail, January 20013

These statements offer a glimpse into a debate that is currently active within the

voluntary health sector Since the early 1990s, advocacy by disease and consumer groups has become a force in health policy Once passive patient organizations are now

outspoken and governments are eager to engage the public in health policy making.4 To advocate effectively, organizations need money for research, training,

decision-community consultation and public education Government policies, which once

supported community-based advocacy, have eliminated or restricted most funding to advocacy groups over the past two decades Any group involved with advocacy is likely

to confront the dilemma of ambitious goals and limited funds, especially for core

operations and advocacy Fundraising and grant writing have become overwhelming requirements for community groups and many, particularly those with a health protection rather than a disease mandate, have ceased to exist

In parallel with these changes in government granting policies, both the pharmaceutical industry and the private sector in general have decreased their undirected donation

programs and increased “partnership” projects and cause-related marketing activities Government policies encourage charitable groups to form partnerships in the private sector; indeed, the Health Products and Foods Branch (HPFB) of Health Canada itself

became a partner with the pharmaceutical industry.a Throughout the health sector,

pharmaceutical companies are now an important source of funding As part of their marketing strategies, drug companies provide grants and other support to patient groups and disease-specific organizations As a result, many groups receive funds from the same companies that are directly affected by policy questions central to their advocacy

Organizations receive tens or hundreds of thousands of dollars annually, sometimes more,b from the drug industry for projects such as conferences, publications, web sites, and advocacy training.5 This trend is occurring at the same time that health researchers, peer-reviewed medical journals, physicians’ professional associations, bioethicists and whistleblowers within drug regulatory agencies are raising red flags over conflicts of interest arising from pharmaceutical company funding in their respective communities The focus of the present discussion is Canada, but the same phenomenon has attracted attention in the US, Europe, Australia and New Zealand.6

Voluntary organizations with a mandate to influence pharmaceutical policies respond to corporate overtures with a range of reactions, from gratitude to caution to alarm Non-profit advocacy groups that are independent of industry, such as Women and Health Protection, PharmaWatch, the Canadian Health Coalition and the Consumer’s

Association of Canada, support a strong government role in drug regulation by

demanding rigorous safety standards, improved post-marketing surveillance, enforcement

of the ban on direct-to-consumer advertising (DTCA) and controls on the proportion of health care funds that are devoted to pharmaceuticals These groups typically define pharmaceutical funding of advocacy groups as problematic Industry-funded non-profits, such as the Consumer Advocare Network and Best Medicines Coalition, contest the assumption that strict government regulations favour the public interest Their demands tend to be consistent with those of industry: rapid drug approvals, legal DTCA and no limits on formulary drug spending Although this dichotomy oversimplifies a complex and fluid picture, the tendency to polarization provides a useful context for the discussion

b Exact figures are difficult to determine as groups are not required to disclose this information and rarely

do Amounts that have been quoted in newspaper articles include: Colorectal Cancer Society of Canada, pharmaceutical companies provide 70% of a $500,000 budget (in Picard, A see citation Endnote 3); Arthritis Society of Canada, $1.8 million of a $30 million budget came from pharmaceutical companies (in Picard, A see citation Endnote 3); the Canadian Breast Cancer Network, in 2000, received $100,000 from Ortho Biotech, a division of Janssen Ortho (in Nebenzahl, D see citation, Endnote 5) PatientView’s survey, based on annual reports and other relevant literature from nine Canadian health campaigning groups in 2001-2003, found that the Canadian Cancer Society, the Canadian Diabetes Association, the Canadian Mental Health Association, the Heart and Stroke Foundation of Canada, the Multiple Sclerosis Society of Canada and the Parkinson’s Society of Canada all cited pharmaceutical company donors (see citation, Endnote 1: pages 22-23)

The discussion looks at current practices against a broad policy context, in particular, the transformation of Canada’s social policies from a welfare state framework to a

governance model that expands the role of private enterprise The unique part that

women’s health organizations play in health protection advocacy is examined Debates in drug policy are examined in light of the impact that funding by drug companies could have on policy decisions, on Canadian health care, on the democratic goals of including consumers and patients in policy discussions, and on advocacy organizations themselves The paper argues that drug company funding of health and disease advocacy groups creates a conflict of interest that needs to be recognized and addressed At the same time,

it acknowledges that advocacy groups operate in a larger policy environment where industry partnerships are now the norm and where the watchdog role of government regulators has been systematically weakened The paper concludes with suggestions for potential remedies and recommendations for policy change

II Conflicts of Interest

A conflict of interest (COI) is said to occur when a person or organization has a primary moral obligation to act on behalf of another and, at the same time, has an interest with a third party that could interfere with proper judgment in the first relationship.7 A health campaigning groupc typically has a self-described mandate to serve the interests of a specific population If a group presents itself as a voice for people with diabetes or breast cancer, or, more broadly, “Canadian consumers”, “women”, or “the public interest”, the organization’s primary moral duty is to act on behalf of this constituency Funding

sources obviously have the potential to create conflicts of interest, especially when the parties providing the money have a direct interest in the outcome of the group’s

advocacy, as drug companies often do

Conflicts of interest don’t have to be financial Other conflicts, such as a desire for

prestige and power, or a personal friendship, might also cloud judgment.8A related

question, now being debated vigorously in the medical literature, is how large a gift has

to be to constitute a conflict The Canadian Medical Association’s guidelines place limits

on what gifts a physician may accept, but allow “modest meals or social events that are held as part of a conference or meeting” and “patient teaching aids appropriate to [a physician’s] area of practice provided these aids carry only the logo of the donor

company and do not refer to specific therapeutic agents, services or other products (e.g., baby formula).”9

By contrast, No Free Lunch, a physician’s organization concerned about conflicts of interest in medicine, argues that even gifts that appear trivial can bias a doctor’s

prescribing habits The group makes its point humorously with a “pen amnesty” program

to encourage physicians to turn in pens bearing drug company logos in exchange for plain ones In the same spirit, No Free Lunch warns physicians about “bagel bias” (the

potential for an inexpensive breakfast to influence prescribing practice) The “zero

tolerance” position on pharmaceutical company gift giving is based in part on the

culturally widespread expectation of reciprocity in gift giving Gifts play a key role in many cultures and even small ones create social obligations of loyalty and friendship.10Psychology experiments on decision-making confirm that self-interest distorts the way individuals weigh arguments These biases are unintentional: even when researchers asked educated participants in a decision-making experiment about the way bias operates, people assumed they would not be biased by a reward but their opponent would be; or they drastically underestimated how strong their own bias would be The same

experiments show that bias is unconscious (people were unable to avoid bias even when

it was in their best interest to do so) Finally, bias was indirect Self-interest changes the way people seek out and weigh information.11

Studies of actual physician behaviour suggest that these conclusions translate to the medical environment House staff who attended grand rounds given by a pharmaceutical company speaker were more likely than their colleagues to prescribe that company’s drug

as treatment, even though they did not remember what company sponsored the grand rounds A study of medical residents found that 61% believed promotions did not

influence their own practice, yet only 16% believed that other physicians were

impervious to influence from promotional gifts Another study found that 19 out of 20 physicians who attended medical education seminars sponsored by two drug companies denied the seminars would influence their behaviour before attending; in fact, use of the companies’ drugs did increase after the seminars Research with physicians has found that bias is strong, even with small stakes Based on their review of psychological and physician practice literature, these authors conclude that attempts to control bias by limiting gift size, by educational initiatives, and by mandatory disclosure are likely to fail because they rest on a faulty model of human behaviour They conclude that the

implication for industry gifts to physicians is straightforward: they should be prohibited.12The existence of a conflict of interest does not necessarily mean that one’s judgment has been, or ever will be, compromised The term refers to a potential for interference

Improper influence is often difficult or impossible to identify.13 Although steps to avoid COI may be resisted as unnecessary, even insulting, they help an organization have confidence in its own decision-making From the outside, conflicts of interest can create a suspicion of bias that undermines public confidence in important institutions Even the potential for wrongdoing, or the appearance of wrongdoing, is enough to undermine an institution’s authority

Conflicts of Interest and Government Funding

Some advocacy groups, including Women and Health Protection, receive funding from the federal government Because governments are not the primary constituency of health advocacy groups, and governments have a budgetary and political interest in what

policies are enacted, government funding of advocacy groups must be characterized as conflicted Unlike the private sector, however, governments have a responsibility to develop policies in the public interest

In his analysis of pressure groups in Canada, political scientist Paul Pross notes that public funding of interest groups, “brings with it problems of uncertainty, dependence, and a tendency to distort the goals of their organization.”14 The government may see the group as an instrument in achieving its goals, while the group may “gradually and almost unconsciously accommodate itself to the funder over time.”15

Despite these problems, Pross argues that, if no advocacy groups received government support, some points of view would be excluded from public debate and the decision not

to fund anyone would automatically favour the views of well-resourced sectors Losing the voices of excluded parties “would weaken not only those sectors but the quality of public debate.”16 The real issue becomes finding a way “to structure the processes of group-state relations so that the dangers of intimidation, favouritism, and manipulation are minimized,” he concludes.17

III Canada’s Health Policy Environment

In 2000, the HPFB established the Office of Consumer and Public Involvement

(OCAPI)18 to encourage public involvement in the Branch’s priority-setting, programs

and policy decisions The Policy Toolkit for Public Involvement in Decision Making,

published by Health Canada, defines the public as “individuals, consumers, citizens and special interest groups such as environmental, health, consumer and voluntary groups, and industry, scientific and professional associations.”19 Canadian consumer, health and patient groups testify regularly at public hearings on pharmaceutical issues, sit on policy committees where drug policy decisions are made, attend workshops and consultations, and meet with health department decision-makers to discuss changes to drug policy Groups that take an active interest in pharmaceutical policy issues include the Best Medicines Coalition and its member groups,d the Consumer Advocare Network, the Canadian Health Coalition, PharmaWatch and Women and Health Protection

Some organizations, including Women and Health Protection, have pressed the HPFB and OCAPI to address the issue of conflicts of interest At the time of this writing,

OCAPI has circulated a draft proposal that would encourage groups participating in policy consultations to make voluntary statements about their funding sources and other organizational information Unfortunately, experience shows that voluntary statements without enforcement have not worked for other sectors Industry-funded scientists have not disclosed clinical trial results unfavourable to industry, top scientists at the National Institutes for Health in the US failed to disclose lucrative industry contracts to their bosses as required,20 and authors whose articles appear in leading academic journals do not always comply with the journals’ conflict of interest disclosure policies.21

d As of November 2004, members of Best Medicine’s Coalition included Arthritis Consumer Experts, The Arthritis Society, The Asthma Society, Canada’s Association for the 50-Plus, Canadian Arthritis Patient Alliance, Canadian Breast Cancer Network, Canadian Cancer Advocacy Network, Canadian Hemophilia Society, Canadian Hepatitis C Network, Cancer Advocacy Coalition of Canada, HepCURE, Multiple Sclerosis Society of Canada, Tourette Syndrome Foundation of Canada, and Yellowhead Tribal Council Website accessed November 7, 2004 at: http://www.bestmedicines.ca/members.html

Current government policy actively promotes partnerships with industry, in the voluntary sector as well as within government itself Non-profit groups that reject this model as inappropriate for their mandate risk marginalization, both because they are perceived as

“not playing by the rules,” and because their access to funds is severely limited As an example, OCAPI formed a partnership with the pharma-funded Best Medicines Coalition (BMC) At a meeting between OCAPI staff and Coalition members in December 2002, participants recommended that OCAPI “use BMC as an umbrella group in its patient consultation strategy.” While the report noted that OCAPI would also consult with

groups representing the healthy population, BMC was characterized as “more appropriate

to represent the Canadian patient population [italics from original].”22 Some patient advocates and patient groups, however, do not feel an organization funded by the

pharmaceutical industry can address the concerns of patients for unbiased information

about medications and policies that promote safety (see, for example, Colleen Fuller on p.9) By favouring BMC as the official voice of patient organizations, OCAPI devalues the perspective of independent patient groups, regardless of the quality of the arguments

they bring

This analysis exposes a policy contradiction While voluntary groups have been called upon to play an expanded advocacy role, public funding for advocacy has been reined in, through funding cuts and a strict interpretation of the ten per cent rule for registered charities.e The complaint that government policies have muzzled charities, while at the same time increasing their burden of service responsibilities, is widespread in the

voluntary sector.23 Health charities, pressured to find sources of funding outside of

individual donors and government grants, have found that pharmaceutical companies welcome these new partnership opportunities The inescapable question, however, is: whose interests do these reconfigured organizations represent?

IV Health Protection Advocacy and the Role of Women

When the modern era of pharmaceuticals began in the 1940s, many drugs and medical devices were marketed solely or primarily to women, sometimes with disastrous effects

By the time the women’s health movement took shape in the late 1960s and early 1970s, thalidomide and diethylstilbestrol (DES) had alerted women to the dark side of

prescription drugs, legally marketed with false promises and no safety warnings Even the birth control pill, although generally welcomed by women, was rushed to market without adequate testing for dosage and harmful effects When deaths from blood clots began to mount, drug companies suppressed the information.24

Pioneering work by Canadian medical sociologist Ruth Cooperstock and her colleagues

in the 1970s showed that sedatives were being prescribed twice as often to women as to men, primarily for social rather than medical reasons.25 These findings galvanized

women’s groups to protest the medicalization of anxiety Other examples of runaway drug promotion have fuelled women’s anger over the medicalization of normal emotional

e Canada’s tax law restricts policy-related advocacy by a registered charity to ten per cent of its donated revenues

and physiological states, including the marketing of implants for small-breasted women and hormone-replacement therapy (HRT) for women who have passed menopause Medicalization is often achieved through heavy promotion of drugs for off-label

(unapproved) uses One example is HRT, which was approved as a short-term treatment for menopausal hot flashes then promoted as a youth potion requiring indefinite use Another example is Diane-35, approved in Canada as a second-line treatment for severe and difficult-to-treat acne, but promoted to treat mild skin problems and currently being used widely on university and college campuses for birth control.26

The past two decades have brought women’s health issues into the mainstream

Ironically, this evolution has obscured rather than highlighted problems of drug safety and over prescribing The feminist critique of unsafe, over-hyped pharmaceuticals and medical devices now competes with messages from professionalized women’s health organizations whose over-arching goal is to provide women with equal access to health services and treatment Consistent with their contrasting perspectives on biomedical intervention, grass-roots advocacy groups and professionalized women’s health

organizations often differ in their attitudes towards corporate funding

Some women’s health groupsf still play a watchdog role towards both industry and

government These groups have raised alarms about the ties between the pharmaceutical industry and health advocacy groups The dominant model in Canada, as elsewhere, however, is the professionalized health advocacy group with industry partnerships These groups rarely criticize industry practices Since drugs harmful to women’s health

continue to make headlines (some recent examples are HRT, Diane 35 and Accutane), the weakened influence of non-profit groups that speak out on health protection issues is a threat to women’s health

V Conflict of Interest and Health Advocacy Groups

Advocates for Better Care: Myth or Reality?

Groups that have chosen to work in partnership with the pharmaceutical industry reject

suggestions that these partnerships lead to co-optation In a 2001 Globe and Mail

article,27 Denis Morrice of the Arthritis Society of Canada, Barry Stein of the Colorectal Cancer Society of Canada, and Durhane Wong Reiger of the Anemia Institute for

Research and Education vigorously defended their decisions to accept funding from the drug industry They saw such partnerships as a way to meet the medical and information needs of an increasingly sophisticated, demanding consumer who understands how the drug approval system works: “People want better patient care, that includes better drugs,” said Barry Stein Denis Morrice stated, “People with arthritis have to benefit or there won’t be a partnership, no matter how much money is offered.”

f Examples are Women and Health Protection and some of its founding member groups: DES Action Canada, the Canadian Women’s Health Network, la Fédération du Québec pour le planning des naissances, and Breast Cancer Action Montreal

As evidence of their ability to maintain independence and uphold ethical standards, they cited policies of being “upfront” about industry financial assistance (Stein), of taking money from multiple companies, including those in direct competition with one another (Morrice), and a willingness to be selective about which companies they worked with (Wong Reiger) Durhane Wong Reiger stated that she ruled out companies who were “too obsessed with the bottom line” in favour of those that were “open-minded” or “truly benevolent.” Industry spokesman Murray Elston, speaking for the industry lobby group Rx&D Canada, echoed this vision of a new breed of information-hungry consumer, responding to government demands to take control of her health In his view, leaders in the associations were part of an empowered vanguard, “starting to use that power to demand changes, and to ask some tough questions.”

If these groups represent an empowered public, how is that power being exercised? What

“tough questions” are being asked? The article notes that groups like the Arthritis Society have become “far more militant and outspoken about issues like the slow approval of new drugs and reluctance to place new drugs on formularies.” Denis Morrice, the Arthritis Society’s president and CEO, considered it coincidental that these same issues also

“happen to be foremost on the minds of corporations.”

The assertions in this article echo the views stated in other media accounts about “pharma partnerships” that have appeared in the past years.28 These claims need to be closely examined since those who make them speak for groups whose mission is to represent the health interests of millions of Canadian patients.g Recurrent themes are the assumption that the “newest” medications are the “best” treatments; that slow approval of new drugs

is a pressing policy problem; that more information, including the content of

advertisements, is necessarily empowering; that sick people have a right to all new

medications on the market, with full coverage; that unlimited access to medications promotes better health; that groups can ensure independence from corporate sponsors with internal policies such as openness; and that drug company funds are the only option available to voluntary groups working in the health sector Some of these claims are examined below

Are new medications the best treatments?

New drugs are not necessarily better than older drugs; in fact, they are often neither as effective nor as safe Even though there are many cases where older, less expensive drugs are better than newer drugs that replace them, the conviction that a newer drug must be better than an old one is pervasive

Patients with diabetes had to lobby to keep cheaper forms of insulin they could use on the market when a newer product proved dangerous or fatal to some diabetics Colleen Fuller was one of hundreds of diabetics in Canada and the US who suffered blackouts,

disorientation and other severe symptoms (including sudden death) when they took the new drug Fuller turned to the Canadian Diabetes Association (CDA) for help in

g The Arthritis Society of Canada and the Colorectal Cancer Society are both members of Best Medicines Coalition, which claims to represent 10-15 million chronically ill patients in Canada For full reference, see Endnote 52:8

convincing Eli Lilly to keep animal insulin on the market, noting that 43 % of the CDA’s members responded in a survey that they had trouble adapting to the new, genetically engineered insulin The CDA said they had asked Eli Lilly, and a competitor that had also discontinued animal insulin, to keep the animal insulin on the market When the drug companies said their decisions were final, the CDA (which in 2001-2003 acknowledged funding from Eli Lilly and 20 other pharmaceutical companies29) did nothing to fight the decision.30

The myth that new drugs are always better than old ones persists partly because new treatments are rarely tested against competing older drugs; rather, they are tested against

a placebo The fact that a drug is approved by a national drug regulator simply means it was found, in a small, limited-term experiment, to be better than nothing Most “new” drugs are not actually therapeutic advances either A substantial number are competing formulations of drugs already on the market, known as “me too” drugs An example is the drug Nexium for heartburn, which AstraZeneca introduced and promoted when the patent was about to expire on its best selling Losec

Are slow drug approvals a problem?

Before drugs can be sold on the Canadian market, the HPFB reviews and assesses the safety and efficacy data that pharmaceutical companies are required to provide The industry has long complained that bureaucratic approval processes cause a “drug lag”, which in turn denies life-saving new treatments to sick patients

The same policies have also attracted patient and consumer group lobbies funded groups generally align themselves with pro-industry positions For example, members of Best Medicines Coalition, a national umbrella lobby for patient groups that receives funding from the pharmaceutical industry, argue that Canada’s drug approval system is too slow and that patients are being denied prompt access to important new drugs A number of groups which do not accept pharmaceutical company funding,

Industry-including Women and Health Protection, PharmaWatch, the Consumers’ Association of Canada and the Canadian Health Coalition, argue that the push to speedy drug approvals detracts attention and resources from the careful drug review and post-market

surveillance needed to assure drug safety

In the early 1990s, due to government cutbacks in Canada and restrictions in the US, the HPFB and the Food and Drug Administration (FDA) instituted user fees payable by industry In return, the regulatory agencies agreed to speed up approvals.h While this policy shift benefits the industry by bringing new, expensive drugs to market sooner, a number of studies of the FDA suggest the cost to consumers may be lower standards of drug safety One study by researchers in the UK compared drug approval times and safety records in the US and the UK over a 20-year period They concluded that the superior safety record of drugs in the US prior to 1992 came from a meticulous and rigorous review process and a political culture of independence from industry within the FDA.31 The Washington-based Public Citizen’s Health Research Group (HRG) surveyed

h In the US, faster approval times were written into law; in Canada, it was an understanding between the drug industry and Health Canada that approval times would be shortened

FDA reviewers in 1998 for their reaction to the changes in the agency Nineteen out of 53 medical officers identified a total of 27 new drugs in the past three years that they thought should not have been approved but were; 17 said that standards were “lower” or “much lower” than they had been three years previously.32 A subsequent survey by the Office of the Inspector General confirmed some of these findings Although 64% of FDA

respondents had confidence in the FDA’s decisions regarding the safety of a drug, at the same time, 40% who had been at the FDA at least five years indicated that the review process had worsened during their tenure, with less allowance for in-depth, science-based reviews.33

Speedy access to experimental drugs is a hollow victory for patients if those drugs cause more health problems than they remedy

Does the ban on DTCA deny information to patients?

All western countries heavily regulate prescription drug advertising to control fraud and the exploitation of fears about health and illness Since the 1990s, drug companies have lobbied heavily for the right to promote their products directly to consumers Their

greatest success has been in the US, where the FDA relaxed restrictions on broadcast DTCA in 1997

Some health campaigning groups have lobbied strenuously to have DTCA legalized in Canada while others have opposed DTCA A brief to Health Canada by the Consumer Advocare Network, another national advocacy umbrella supported by the pharmaceutical industry, argues that the Canadian ban on DTCA denies patients their “fundamental right

to information about prescription drugs, which includes direct-to-consumer advertising,

or promotion, of drugs.”34 Groups that maintain financial independence from the

pharmaceutical industry oppose DTCA on the grounds that advertising does not provide patients with the unbiased information they need to make informed health decisions.35

Do people have a “right” to new medications, with full insurance coverage?

Each province has a formulary that restricts drug coverage to a subset of all available drugs After Health Canada approves a drug, each provincial or territorial government will assign that drug to one of three categories: covered, not covered or limited use (i.e., the government will only pay for the drug under certain conditions or, in some cases, prescriptions for that drug will be filled by a comparable lower priced drug) The high cost of many new drugs creates a dilemma for provincial governments, working within strained health budgets A drug that has been approved will not necessarily be added to all (or any) provincial formularies if a government decides its cost exceeds the health benefit or if the drug is simply unaffordable.36

Advocacy groups again differ in their responses if a province decides not to add the drug

to its formulary A common response has been for groups of patients who feel they are being denied a drug to demand that it be added to the formulary These drug access

lobbies often include a media appeal by a suffering patient, demands for formulary

inclusion by the spokesperson from a relevant disease group, and statements dismissing concerns about the cost

The Fabry Society of Canada launched such a lobby after Health Canada approved

Fabrazyme and Replagal,i drugs which had been shown in clinical trials to make patients feel better but which had not yet shown any survival benefit The Common Drug Review,

an expert panel established in September 2001 to advise the federal, provincial and territorial governments on which drugs and devices to cover, recommended against having the two Fabry’s treatments added to government formularies The review panel based its ruling on the treatments’ quarter-million dollar annual cost per patient, and the lack of demonstrated benefits based on clinical endpoints When asked if the high cost of the drug was warranted, Ed Koning, a patient who chairs the Fabry Society of Canada, responded, “The cost is not the patient’s issue.”37

Members of patient groups responded similarly when Wyeth-Ayerst’s drug Enbrelj was approved and the government of Newfoundland decided not to add it to the formulary The idea that drugs should be added to provincial formularies as soon as they are

approved rests on the contention that patients have a “right” to any new treatment that might help them, regardless of costs AIDS activists laid the foundations for this

argument in the 1980s They opposed the strict regulatory procedures that had been developed in response to the thalidomide tragedy and demanded free access to

experimental drugs outside of clinical trials as a right.38 Other patient groups have

adopted the arguments of AIDS activists and expanded them to include patients suffering

from illnesses that are not terminal In a Globe and Mail article about disparities between

provincial drug formularies, the president of Best Medicines Coalition, Kathy Kovacs Burns, was quoted as saying, that “ ‘cost containment’ should not be part of any national drug plan,” and the “best drugs” are not likely to be the “cheapest or oldest” drugs

available.39 Other industry-funded advocacy groups have suggested that patients have the right to sue provincial governments that don’t add drugs for their condition to

formularies.k 40

By contrast, groups that remain independent of the industry focus on whether

exaggerated claims have been made for the new drug, whether it is significantly more effective and/or safer than less costly treatments, and whether the pricing is excessive

Dr Joel Lexchin, a member of the independent groups Women and Health Protection and

PharmaWatch, commented to the Ottawa Citizen in an article on drug costs, “The market

has a set of values and it does not operate in the interests of public health, it operates in the interest of making money.” He added, “What general practitioners should be getting

is comparative information: Where does this drug fit into the spectrum of therapy? But it

is often difficult to get this kind of information.”41

i

Fabrazyme and Replagal, developed to treat a rare hereditary condition called Fabry’s disease, are priced

at $240,000 and $290,000 annually per patient respectively.

j Enbrel, a drug approved for pain relief from rheumatoid arthritis, costs upward of $20,000 per patient per year

k In November 2004, the Supreme Court of Canada ruled unanimously that Charter protection against discrimination does not require provinces to add an expensive treatment to their formulary

Although drug prices are closely related to provincial formulary decisions, drug pricing

in itself has been a neglected area for direct lobbying by patient and health advocacy groups in Canada An exception is a 2003 brief by Richard Elliott for the Canadian HIV/AIDS Legal Network, which includes recommendations for amendments to the Patent Medicines Prices Review Board guidelines and the Patent Act The

recommendations include distinguishing between the pricing of “breakthrough” drugs and those that offer little or no therapeutic advantage over existing drugs, and allowing a

“reasonable” profit margin over and above the costs of development and manufacture.42 More typical responses to rising drug costs from patient groups are those cited above – that drug costs are “not the patient’s issue” and cost containment “should not be the basis

of any national drug plan.”43

No public system can give every sick person everything they want A public health care system implies sharing resources, spreading available resources across many services and prioritizing on the basis of need and evidence Ultimately, the excessive cost of new medicines is a political issue that needs to be confronted, but industry-funded patient groups have not chosen to take this on

Do industry-funded groups empower patients?

Patient empowerment is prominent in the rhetoric of industry-funded groups The power supposedly comes from providing patients with information about new drug treatments for their disease, and from the muscle to lobby governments for access to these products The close correspondence of advocacy group views with those of their industry sponsors suggests this empowerment is more illusory than real True empowerment comes from having independent information about diseases and their treatments, and tools to critically analyze a problem Is it coincidence that pharma-funded groups focus their criticism of government on issues like “drug lag”, formulary access to new drugs and the ban on DTCA, while groups independent of the industry critique government partnerships with industry that have weakened the government’s monitoring of drug safety and misleading claims? Based on the analysis presented in this paper, the answer is no

This critique is not meant to suggest that health campaigners who form partnerships with pharmaceutical companies intentionally align their goals with their industry sponsors Most groups would prefer not to accept funding from the pharmaceutical industry, but they have few alternatives.44 The dilemma for many is that any funding is better than no funding and industry funding allows them to mount programs to serve their communities that they could otherwise not afford Having accepted industry money, however,

organizations become blind to its co-opting effects

As discussed in section II, studies in the medical community and psychology experiments

on decision-making show that conflicts of interest create very subtle biases They are unintentional, unconscious and indirect – but that doesn’t diminish their potential for harm Consider the two blockbuster arthritis drugs, Pfizer’s Celebrex and Merck & Co.’s Vioxx In 2000, the Arthritis Society of Canada lent its logo to a newspaper supplement extolling the two drugs that had just come on the market The Arthritis Society receives funding from both drug manufacturers According to the president of the Arthritis